Evaluation of a programme of cardiovascular disease prevention in primary care
| ISRCTN | ISRCTN32114200 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32114200 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/04/2009
- Registration date
- 28/05/2009
- Last edited
- 17/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims.
We know that many patients who are at high risk of heart disease or stroke do not receive treatment. Treatments include drugs to lower blood pressure and drugs to reduce cholesterol levels (statins). A new process was put in place in general practices in Sandwell (West Midlands) to help identify untreated patients at high risk of heart disease. The aim of this study was to find out whether this process resulted in more high risk patients being started on treatment. If successful the study may lead to similar systems being adopted in other parts of the UK, which should result in more successful prevention of heart disease and stroke.
Who can participate?
The participants in this trial were general practices in Sandwell (West Midlands). Individuals identified as being at high risk of heart disease in these participating general practices were invited for check ups.
What does the study involve?
In the participating general practices the general practice computer system was used to identify patients who are at high risk of heart disease or stroke but are currently not receiving any treatment. The study included only patients aged 35 to 74 who do not already have heart disease or diabetes: patients with heart disease or diabetes should already be receiving treatment. The patients identified by the computer system as high risk were sent letters inviting them for a check up in their own general practice by a Project Nurse. The letter indicated that they might be offered treatment. The plan was to introduce this system across all general practices in Sandwell. However, it was not possible to implement this in all practices at the same time. Practices were randomly allocated to have the computer search and Project Nurse earlier or later in the course of the project. In order to determine whether this is an effective way of identifying high risk patients for treatment, the study looked at how many high risk patients were started on treatment before the computer search was undertaken and how many were started on treatment after the computer search was carried out, the invitations were sent and the Project Nurse was undertaking check ups in the practice.
What are the possible benefits and risks of participating?
General practices that participated received help in identifying their high risk patients. Those patients identified were offered lifestyle advice and drugs to prevent heart disease in accordance with good medical practice. There were no risks associated with participating in the research programme.
Where is the study run from?
The study was run from the School of Health and Population Sciences of the University of Birmingham.
When is the study starting and how long is it expected to run for?
The study began in 2009 and is now completed.
Who is funding the study?
It was funded by the National Institute of Health Research (UK).
Who is the main contact?
Dr Tom Marshall
T.P.Marshall@bham.ac.uk
Contact information
Scientific
Unit of Public Health Epidemiology and Biostatistics
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of a programme of cardiovascular disease prevention in primary care: a cluster randomised controlled trial |
| Study objectives | A programme of case finding targeted at high risk patients will result in more patients being started on preventive treatment than usual care. On 10/07/2013 the target number of participants was changed from 1,254 to 6,250 |
| Ethics approval(s) | University of Birmingham ethics review committee, 07/06/2010, ERN_10-0429 |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | This is a step-wedge cluster randomised controlled trial. Targeted case finding is being implemented in general practices. Practices are randomised to early (intervention) or later implementation (control). Interventions: Systematic invitation and cardiovascular risk factor assessment of individuals aged 35 to 74 who are untreated but at high risk of cardiovascular disease. These individuals will then be referred for appropriate lifestyle advice or preventive treatment in accordance with good clinical practice and treatment guidelines. |
| Intervention type | Other |
| Primary outcome measure | Number of eligible patients started on preventive treatment (aspirin, antihypertensives and statins). All primary and secondary outcomes will be assessed at 3 months, 6 months and 1 year after the start of the study. |
| Secondary outcome measures | 1. Changes in blood pressure, total cholesterol, HDL cholesterol and smoking status Process outcomes: 2. Numbers of persons attending for CVD risk factor assessment 3. Numbers of those assessed who are confirmed as being eligible for treatment All primary and secondary outcomes will be assessed at 3 months, 6 months and 1 year after the start of the study. |
| Overall study start date | 01/02/2008 |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | At least 6,250 participants in at least 6 practices |
| Key inclusion criteria | Participating practices are identified by the participating primary care trusts. Patients for inclusion in the prevention programme are identifed as follows. They must be registered at a participating practice. They must be aged between 35 and 74 and must not currently have coronary heart disease (CHD), not be on the diabetic register and not be currently receiving antihypertensive or statin treatment. From these patients are identified all those patients in whom a combination of risk factors indicates they are likely to be at greater than 20% ten-year risk of cardiovascular disease. These patients are considered eligible for inclusion in the cardiovascular prevention programme. These patients will be identified from primary care electronic medical records. In summary: 1. Patients (both males and females) aged between 35 and 74 2. Patients who do not have CHD 3. Patients who are not diabetic 4. Patients who are not receiving antihypertensives or statins 5. Patients who are likely to be at greater than 20% ten-year CVD risk |
| Key exclusion criteria | Patients who in the opinion of the practice staff are unable to benefit from cardiovascular risk factor assessment. For example, patients who are terminally ill. In practice this means that once a list has been created of individuals who are untreated high risk patients are eligible to be invited for cardiovascular risk factor assessment, practice staff will review the list and identify patients who are known to be terminally ill or otherwise unsuitable for inclusion. |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 01/05/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
B15 2TT
United Kingdom
United Kingdom
Sponsor information
Hospital/treatment centre
PO Box 9551
Main Drive
Queen Elizabeth Medical Centre
Birmingham
B15 2PR
England
United Kingdom
| Website | http://www.uhb.nhs.uk |
|---|---|
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | No further publications planned |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/10/2012 | Yes | No | |
| Results article | results | 01/10/2016 | Yes | No |
Editorial Notes
17/08/2018: Publication reference added and the publication and dissemination plan was updated from "To be confirmed at a later date" to "No further publications planned".
